MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPACEOAR VUE SYSTEM; ABSORBABLE PERIRECTAL SPACER

Model Number SV-2101

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Discomfort (2330); Fluid Discharge (2686); Constipation (3274); Swelling/ Edema (4577)

Event Date 12/19/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure in (b)(6) 2023.The procedure was performed under sedation.Fiducial markers were placed transperineal prior to injection.It was noted that the patient did not respond well during the placement procedure and moved unexpectedly during the injection of the hydrogel.The patient experienced pain immediately after the placement procedure.During the evening after the placement procedure, the patient was urinating and had a "plug" come out, described as a hydrogel like substance.The patient called the physician and was told to go to emergency department (ed).Swelling the size of a golf ball was noted around the anus, the patient reported that it feels like pulling.The patient's bowel movements were noted as not normal and flat.The patient also reported constant feeling of constipation.On (b)(6) 2023, the patient went for a simulation, however the patient was having severe pain and having swelling of right buttock/groin.The patient waited three days in the emergency room (er) for cultures that resulted negative.Antibiotics were given at the hospital.Later on, (b)(6) 2023, the physician reported that the patient complained of rectal pain and pressure, the patient stated that he cannot sit.A computed tomography (ct) showed a possible rectal wall infiltration of the hydrogel into the prostate.The patient was planned for external beam radiation and is still waiting for radiation until his current condition is resolved.

Manufacturer Narrative

Block d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a1502 captures the reportable event gel misplaced - non-vascular.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2338 captures the reportable event of swelling.

• Brand Name: SPACEOAR VUE SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18540316
• MDR Text Key: 333194626
• Report Number: 2124215-2023-75871
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000140
• UDI-Public: 00864661000140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SV-2101
• Device Catalogue Number: SV-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male